MAUDE Adverse Event Report: NEOMED, INC. NEOCONNECT ENTERAL EXTENSION SET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	PEXT-60NC
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019 - on two separate incidences occurred (in the span of 24 hours) for purple feeding extension tubes leaking milk onto the bed at the connection between the end of the ng tube and the feeding extension tube.There were no cracks or holes seen in the tubing and the connections seemed secure.The cause of both events are unknown, so we are tracking occurences to help spot trends.On (b)(6) 2019 - during shift handoff at 0600, infant enfit feeding tube enteral extension set was fosund to be leaking formula at patient side connector with a moderate amount of formula noted on burp cloth.Leaking was noted by both day and night shift rn's.Feeding extension set was changed and feeding continued without further leakage.On (b)(6) 2019 - feeding leaking from extension set.Second time this week.This is a replacement product due to a back order.On (b)(6) 2019 - feeding extension tubing leaked.On (b)(6) 2019 - enfit feeding extension tubing leaked.

• Brand Name: NEOCONNECT ENTERAL EXTENSION SET
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): NEOMED, INC.; 100 londonberry court; suite 112; woodstock GA 30188
• MDR Report Key: 9271485
• Report Number: 9271485
• Device Sequence Number: 3660322
• Product Code: KNT
• UDI-Device Identifier: 00817584012028
• UDI-Public: (01)00817584012028(17)220710(10)20190711
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/23/2019
• Report Date (Section F): 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PEXT-60NC
• Device Catalogue Number: PEXT-60NC
• Device Lot Number: 20190711
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/23/2019